Audit Management Software Systems

Audit Management Software Systems for Life Science and Other Regulated Companies

An audit management software system greatly reduces the time and effort needed to pass an audit. The software automates audit-related tasks to simplify the process and can integrate with a document control system to ensure necessary documentation can be found and accessed. In many cases, reliable audit management software is the difference between passing and failing an audit.

Product Videos

Hundreds of companies around the world use MasterControl to automate core business processes and document management activities to promote collaboration, improve decision making, and accelerate time to market.

Free Resources

Quality Audit - A Tool for Continuous Improvement and Compliance
The Top 5 Benefits of Electronic GLP Audit Management
How to Successfully Complete an FDA Inspection

Toolkit:

8 Free Resources to Boost Your Audit Management System

e-Book:

Compliance and Technology: How to meet changing FDA expectations

Webinar:

FDA Just Left! Now What?

QuickStart Cards:

11.x MC QuickStart Card for Users-Readers

How MasterControl Audit Management Software Helps You

MasterControl Audit™ makes audits faster, easier and more effective. The audit software provides a comprehensive overview of every step in the audit process — from preparation to completion — thereby ensuring compliance. It seamlessly connects with other quality processes, such as corrective/preventive action (CAPA), supplier management and risk management.

Audit Management System Challenges

MasterControl Audit Solution

Disconnected Audit Management System

Knowing what to audit and how often requires input from other quality systems, which is difficult to gather when dealing with a disconnected system.

Connected Audit Management Software

MasterControl Audit integrates with other quality systems, such as supplier, risk and CAPA, which streamlines the process and ensures issues raised during audits are properly addressed.

Inefficient Audit Scheduling

Planning and scheduling audits can be deceptively complex, especially managing the associated resources to make sure everything is done on time.

Advanced Audit Scheduling

MasterControl automates audit scheduling and related activities, ensuring that nothing gets overlooked. The audit calendar provides a holistic overview of all audits and scheduling conflicts are highlighted for easy resolution.

Audit Management Results Lack Visibility

Without a way to incorporate and analyze data from multiple audits, managers are unable to see the big picture of where a company stands.

Increases Visibility

MasterControl Audit has powerful analytics and reporting capabilities that give a real-time view of the audit process and quality system. Managers can easily track issues raised during audits and ensure that they are resolved.

What Sets MasterControl Apart?

MasterControl Audit makes audits easy to conduct and schedule. Microsoft Word and Outlook can be used during audits and a simple drag-and-drop calendar is used for scheduling. Follow-up is also simplified with automated report creation and seamless integration with quality processes involved in issue resolution.

Benefits of the MasterControl Audit Management System

Connected Audit Management and Quality ManagementIntegrates all steps in the audit process — from preparation to completion — and all aspects of quality management, such as CAPA and supplier management.

Improved CollaborationAccessible from virtually anywhere because it is web based. Allows those who aren’t MasterControl users to still access the system via a guest connection.

Centralized Audit ManagementAllows advanced audit scheduling for multiple audit types and enables multiple auditors to collaborate from a single workspace.

Standardized Audit ProcessAllows multiple checklist templates to be created for different audit types, and templates can be used across the organization.

21 CFR Part 11 CompliantLimits access to authorized users and requires a dual-password approval process. Employs a secure, time-stamped audit trail that records the identity of those creating, modifying or deleting records.

The QMS Provider for the FDA

MasterControl Inc. and its partner, i4DM, are expanding their FDA project, serving as the QMS providers for a second FDA division. The two companies have been the QMS providers for the FDA's Office of Regulatory Affairs since 2009. Now they will also serve as quality providers for the Division of Pharmaceutical Analysis, which is part of the FDA's Center for Drug Evaluation and Research.